Identifying New Genetic Causes to the Disorders of Growth, Puberty and Sex Development

Identifying New Genetic Causes to Development Disorders



Sponsors


Source

Fondation Ophtalmologique Adolphe de Rothschild

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Disorders of growth, puberty and sex development can have genetic causes. The exome analysis
could detect new mutations responsible for these disorders and the frequency of these
mutations in these disorders, their association with other malformations.

Overall Status

Recruiting

Start Date

2017-02-21

Completion Date

2027-02-21

Primary Completion Date

2027-02-21

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

mutation research
baseline

Number Of Groups

1

Enrollment

1100

Conditions


Intervention

Intervention Type

Genetic

Intervention Name


Description

search for genetic mutations

Arm Group Label

Growth, puberty, sex development disorders


Eligibility

Study Pop

Patients with disorders of growth, puberty and sex development and related subjects.

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- congenital growth hormone deficiency

- puberty disorder

- gonadal dysgenesis or anorchia

- primary ovarian failure

- disorder of sex development

- subjects related to a patient with one of the above criteria

Exclusion Criteria:

- environmental or auto-immune cause

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Raja Brauner, PU-PH
Principal Investigator
Fondation Ophtalmologique A. de Rothschild

Overall Contact

Last Name

Laurence Salomon, MD, PHD

Phone

+33 148 036 431

Email



Location

Facility

Status

Contact

Fondation Ophtalmologique A de Rothschild
Paris 75019 France
Recruiting
Last Name: Laurence Salomon, M.D.
Phone: 0033148036431
Email: [email protected]

Location Countries

Country

France


Verification Date

2017-09-01

Lastchanged Date

2017-09-13

Firstreceived Date

2017-09-13

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Growth, puberty, sex development disorders

Description

blood sample


Firstreceived Results Date

N/A

Acronym

FORDEV

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Cross-Sectional



ClinicalTrials.gov processed this data on September 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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